UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy study of the carbon ion radiotherapy in 16 fractions for castration refractory prostate cancer
Title of the study (Brief title)	GUNMA1103
Region	Japan

Condition
Condition	castration refractory prostate cancer
Classification by specialty	Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the efficacy of the carbon ion radiotherapy in 16 fractions for non-metastatic castration refractory prostate cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5-yr biochemical relapse free survival
Key secondary outcomes	1) 5-yr overall survival 2) 5-yr cause specific survival 3) 5-yr local control 4) acute toxicity 5) late toxicity 6) QOL

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male
Key inclusion criteria	1) Continuous PSA increase in spite of castration level of testosterone. 2) Histologically proven primary prostate adenocarcinoma 3) Gleason score is diagnosed 4) T1c-T3N0M0(2009, UICC 7th) 5) PSA value before biopsy and before this study are measured 6) No lymph node and distant metastasis 7) Age at registration is 20-80 8) Performance status is 0-2 9) Diagnosis is informed 10) Having the ability to consent
Key exclusion criteria	1) Past radiotherapy to the pelvic region 2) Past physical treatment of the prostate (TUR-P, HIFU, etc.) 3) Past chemotherapy within 4 weeks 4) Life expectancy is less than 6 months 5) Multiple malignancies within 5 years 6) Severe comorbidity 7) Judged inappropriate for this study by physicians
Target sample size	50

Research contact person
Name of lead principal investigator	Kazuhiro Suzuki
Organization	Gunma University
Division name	Urology
Address	3-39-22 Showa-machi, Maebashi
TEL	(027)220-8300
Email	kazu@gunma-u.ac.jp

Public contact
Name of contact person	Hidemasa Kawamura
Organization	Gunma University
Division name	Heavy ion medical center
Address	3-39-22 Showa-machi, Maebashi
TEL	027-220-8378
Homepage URL
Email	kawa@gunma-u.ac.jp

Sponsor
Institute	Working group of heavy ion therapy for genitourinary tumor, Gunma university
Institute
Department

Funding Source
Organization	Gunma University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 03 Month 08 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Check the symptoms, laboratory tests, radiological tests and QOL scores periodically.

Management information
Registered date	2015 Year 03 Month 10 Day
Last modified on	2017 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019421